United States Patent [w]
Stewart et al.
US005931824A [ii] Patent Number: [45] Date of Patent:
[54] IDENTIFICATION AND ACCOUNTABILITY SYSTEM FOR SURGICAL SPONGES
[76] Inventors: William W. Stewart, 426 N. Foy's Rd., Kalispell, Mont. 59901; Brian E. Stewart, 11982 Kiowa 306, Los Angeles, Calif. 90049
[21] Appl. No.: 08/921,430 [22] Filed: Aug. 29, 1997
Related U.S. Application Data
[60] Provisional application No. 60/025,629, Sep. 4, 1996.
[51] Int. CI.6 A61F 13/15; A61F 13/20
[52] U.S. CI 604/358; 604/362
[58] Field of Search 604/358, 362,
604/385.1
[56] References Cited
U.S. PATENT DOCUMENTS
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Primary Examiner—Mark O. Polutta [57] ABSTRACT
An automatic identification system for accounting for and identifying a plurality of surgical sponges used during a surgical procedure. Machine-readable information is located on a plurality of surgical sponges. Each sponge of the plurality of surgical sponges has unique machine-readable information located thereon. The unique machine-readable information is unique for at least one surgical procedure.
28 Claims, 2 Drawing Sheets
1
IDENTIFICATION AND ACCOUNTABILITY
SYSTEM FOR SURGICAL SPONGES
This application is a provision of Ser. No. 60/025,629 filed Sep. 4, 1994. 5
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to an identification and accountability system for surgical sponges and more particularly to an identification and accountability system for 10 surgical sponges, which utilizes machine-readable information to identify and account for surgical sponges.
2. Description of the Related Art
Surgical sponges are commonly used during surgical procedures to absorb body fluids, mostly blood, of the patient both inside the incision and around the site of surgery. Sponges of this nature are usually made of an open ended absorbic fabric, such as woven cotton. When used, surgical sponges become saturated with blood, alter in size 2Q and shape and therefore become hard to distinguish from body tissue and each other. For this reason surgical sponges are hard to identify and account for both during and after a surgical procedure. This problem becomes magnified in larger surgical procedures where there are a large number of 2J sponges used.
Before any particular surgical procedure all surgical items must be meticulously counted. After the procedure all items used in that particular surgery must be identified and accounted for. Surgical sponges are a difficult item to 30 account for before, during and especially after a surgical procedure. The current method of identification and accountability relies on medical personnel to count these items by hand, relying on human visual detection and counting ability to differentiate one sponge from another and 35 account for all the sponges, leaving this method open to a degree of human error. If a sponge count taken during or after a surgical procedure does not match a sponge count taken during or after the same procedure, the sponges are impregnated with an x-ray detectable element so that the 40 patient can be x-rayed to see if the missing sponge or sponges are inside the patient and where.
The current system of accountability and identification for surgical sponges has proven itself unreliable and inefficient. Not only does the large amount of time involved to differ- 45 entiate the sponges from one another and account for them all lead to large costs, but also the unreliable nature of the method leads to an alarming number of miscounted sponges resulting in retained surgical sponges inside the patient. These unfortunate incidents adversely affect not only the 50 health of the patient, but also prove costly to the nurses, technicians, doctors, hospitals and insurance companies involved.
Past attempts have been made to increase the chances of accurate visual counting of surgical sponges. U.S. Pat. No. 55 4,917,694 addressed this problem by including, in the sponge, an elongated visually detectable element at a visible location on the sponge comprising a pair of elongated twisted strands. One of the strands contrasts with the color of the sponge, and the other with the color of blood. This is 60 done to facilitate visual detection of the sponge whether it is dry or soaked with blood. This is done to facilitate visual detection of the sponge and counting ability and is therefore subject to a high degree of human error. There is no attempt to differentiate one individual sponge from another. 65
U.S. Pat. No. 4,114,601 attempts to solve the problem of medical item detection. It describes a method by which
2
surgical implants, instruments, sponges, implantable devices and indwelling therapeutic devices and materials may be detected within the human body, or other area of interest, by incorporating or adding a radio frequency transponder. Nonlinear mixing of two frequencies in a radio transponder is used. This transponder may be a small film deposition of ferrite material exhibiting gyro-magnetic resonance at selected frequencies or a solid state device. When the transponders are incorporated in the items, the detection of the transponder is equivalent to the detection of the implant.
U.S. Pat. No. 5,031,642 also attempts to address the issue of medical item accountability. The invention is an "Integrator Collector" containing a time-correlated digital receiver for measuring, displaying and recording fluid loss from surgery and for maintaining, displaying and recording a count of secured items, such as needles and sponges by means of an electronic beam, which upon activation by a surgical sponge, triggers the automatic conversion of the weight of the items into cubic centimeters of blood loss.
The '642 patent calls for the placement of indicia on external packaging of the containers holding the surgical sponges as a means to count the number of sponges before a surgical procedure, but makes no attempt to include this indicia on the individual sponges themselves. No attempt is made to differentiate one individual sponge from the next by means of indicia.
OBJECTS AND SUMMARY OF THE
INVENTION
It is therefore a principal object of the present invention to account for and identify surgical sponges in an efficient, reliable manner.
It is another object to provide an identification and accountability system for surgical sponges which is not obscured by the conditions that the system will be exposed to in its use, particularly exposure to body fluids including but not limited to blood.
It is another object to provide an identification and accountability system for surgical sponges which does not compromise any medical requirements thereof, particularly but not limited to requirements of sterility.
It is another object to provide this identification and accountability system in a way as not to compromise the function of the surgical sponges.
These and other objects are achieved by the present invention that, in one broad aspect, comprises machinereadable information located on individual surgical sponges. The machine-readable information is unique to each individual surgical sponge, making each and every sponge automatically differentiable from the next for at least a given surgical procedure. Each surgical sponge further preferably includes an x-ray detectable element.
Means are provided for automatically reading the individually unique surgical sponges and creating an inventory of the surgical sponges to be used for a particular procedure. An automated check of the inventory of surgical sponges can be obtained at any desired time before, during or after a surgical procedure.
The present invention provides for the improved identification and accountability of surgical sponges by the incorporation of automatic identification technology to these sponges in a manner that allows for the differentiation of the individual sponges from each other. This is done through the impregnation of unique machine-readable information to each individual sponge that is unique for at least a surgical
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